1. Executive Summary

1.1 The Global Diabetes Market Will Exceed $21 Billion by 2011

1.2 Aims, Scope and Format of the Report

1.3 Research Methodology

2. Introduction: A Background to Diabetes

2.1 Diabetes and Insulin

2.2 The Biology of Diabetes Mellitus

2.3 Metabolic Syndrome and Its Relationship to Diabetes

2.4 Type 1 Diabetes Described

2.5 Causes of Type 1 Diabetes

2.5.1 Auto-immune Response

2.5.2 Genetic Abnormalities

2.5.3 Viruses

2.5.4 Cow's Milk

2.6 Symptoms of Type 1 Diabetes

2.6.1 Hypoglycemia

2.6.2 Ketoacidosis

2.7 Type 2 Diabetes Described

2.8 Causes of Type 2 Diabetes

2.8.1 Insulin Resistance

2.8.2 Genetic Factors

2.9 Symptoms of Type 2 Diabetes

2.10 Gestational Diabetes

2.11 Maturity-onset Diabetes in Youth

2.12 Secondary Diabetes

2.13 Diagnosing Diabetes

2.14 New Diagnostic Guidelines

2.15 Pre-diabetes

2.16 Further Health Consequences of Diabetes

2.16.1 Cardiovascular Disease

2.16.2 Kidney Disease

2.16.3 Blindness

2.16.4 Nervous System Disease and Amputations

2.16.5 Dental Disease

2.16.6 Impotence

2.16.7 Complications in Pregnancy

2.17 Diabetes Tests

2.17.1 Fasting Plasma Glucose (FPG) Test

2.17.2 Glucose Tolerance Test

2.17.3 Test for Glycosylated Haemoglobin

2.17.4 Fructosamine

2.18 Specific Goals of DiabetesTreatment

2.18.1 Benefits of Improved Blood Sugar Control

2.19 Diabetes Risk Factors

2.19.1 Type 1 Diabetes Risk Factors

2.19.2 Type 2 Diabetes Risk Factors

2.19.3 Age of 40 Years or Older

2.19.4 Obesity and Physical Inactivity

2.19.5 Family History of Diabetes

2.19.6 Diabetes During Pregnancy

2.19.7 Ethnicity

2.19.8 Low Birth Weight

2.20 Diabetes Prevalence Will Increase to 370m by 2030

3. The Treatment of Type 1 Diabetes

3.1 Introduction to Insulin

3.2 Types of Available Insulin

3.2.1 Rapid-acting Insulin

3.2.2 Start-activity Insulin

3.2.3 Intermediate-acting Insulin

3.2.4 Long-acting Insulin

3.2.5 Ultra-long-acting Insulin

3.2.6 Insulin Mixtures

3.3 Insulin: A Background to Manufacture

3.4 Insulin Analogues and Proinsulin

3.5 Insulin as a Biogeneric

3.6 Exubera: A Revolution in Diabetes Healthcare

3.7 Extensive Meets Unmet Medical Need

3.8 Exubera - Successful Clinical Trials

3.9 Continued Safety Concerns

3.10 Exubera a Future Blockbuster But When?

4. The Treatment of Type 2 Diabetes

4.1 Various Drug Treatments Are Available

4.2 Classes of Medication

4.2.1 Sulphonyureas

4.2.2 Prandial Glucose Regulators (PGR)

4.2.3 Meglitinides

4.2.4 Biguanides

4.2.5 Thiazolidinediones

4.2.6 Alpha-glucosidase Inhibitors

4.3 The Treatment of type 2 Diabetes by Lifestyle Measures

4.3.1 Diet and Weight Loss

4.3.2 Exercise

4.3.3 Monitoring Blood Glucose

4.3.4 Daily Foot Care

5. The World Diabetes Market, 2005-2011

5.1 Growth Rates in the World Diabetes Market Will Increase in 2007 due to Exubera

5.2 Oral Anti-diabetics Dominate the World Diabetes Market

5.3 Thiazolidinediones Are the Leading Oral Anti-diabetic Drugs

5.4 Takeda Leads the World's Diabetes Market With Actos

5.5 The Price of Insulins and Oral Anti-diabetic Drugs

5.5.1 Exbuera Will Be More Expensive Than Other Insulins

6. The World Thiazolidinediones Market, 2005-2011

6.1 GSK and Takeda Compete for Dominance in the Thiazolidinedione Market

7. The World Sulphyonlyureas Market, 2005-2011

7.1 Sulphyonlyureas Are the Second Most Popular Drug Class in the World Oral Anti-diabetics Market

7.2 Amaryl Dominates the Sulphyonlyurea Class But Will See Declining Revenues Due to Patent Loss

8. The World Biguanides Market, 2005-2011

8.1 Glucophage Will Continue to Earn High Revenues Despite Patent Loss

8.2 Glucophage: A lesson in Life-Cycle Management

9. The World PGR Market, 2005-2011

9.1 Starlix and NovoNorm: A History

10. The World AGI Market, 2005-2011

10.1 The AGI Market Will Show Negative Growth at the End of the Forecast Period

11. The World IM and PPARs Market: New Classes of Oral Anti-diabetics

11.1 Incretin Mimetic

11.2 PPAR

11.3 Byetta Will Earn Blockbuster Revenues by 2011

11.4 Pargluva Will Initially Earn Only Small Revenues After Its Potential Launch in 2010

12. The World Diabetes Market by Country, 2005

12.1 The US Takes Over 55% of the World Diabetes Market

12.2 Oral Anti-diabetic Drugs Generate Higher Revenues than the Insulins

12.3 In the US Nearly 70% of All Diabetic Revenues Come from Anti-diabetic Drugs

12.4 Generics in the US Take Nearly 20% of the Market for Oral Anti-diabetics

12.5 In 2004 Lantus Was the Biggest Selling Individual Insulin Product in the US Market

12.6 The Japanese Oral Anti-diabetic Market Shows Low Growth

12.7 The Japanese Insulin Market Is Dominated by Novo Nordisk

13. The World Insulins Market, 2005-2011

13.1 The World Insulin Market Will Be Worth Over $11bn By 2011

14. Pipeline for Diabetic Treatments

14.1 Unmet Needs for Diabetes Treatments

14.2 Leading Pipeline Products for the Diabetes Market

14.3 Other Agents in Development for Treating Diabetes

14.3.1 Agents in Phase III of Clinical Development

14.3.2 Agents That Have Completed Phase III of Clinical Development

14.3.3 Other Agents For Which Final Regulatory Approval Is Pending

14.4 Other Experimental Studies: Can Immunosuppressant Drugs and Insulin Treatments Suppress Development of Type 1 Diabetes?

15. Insulin Delivery Technologies

15.4 Insulin Jet Injectors

15.5 External Insulin Pumps

16. Promising New Technology for the Treatment of Type 1 Diabetes

16.1 Implantable Insulin Pumps

16.2 Insulin Pills

16.3 Transdermal Insulin

16.4 Oral Spray Insulin

16.5 Organ Transplantation

17. An Analysis of Factors That Influence the Diabetes Market: A SWOT Analysis

17.1 SWOT Analysis of the Diabetes Market

17.2 An Expanding Patient Population Is the Principal Driver in the Diabetes Market

17.3 The Diabetes Market Has Opportunities for Continuing Growth

17.4 Advances in Technology Are Likely to Bring Benefits to the Market

17.5 Generics Pose the Most Significant Threat to the World Diabetes Market

17.6 Generics are the Largest Threat to the Branded Diabetes Market

17.7 What Unmet Market Needs Exist in the Diabetes Market? - Experts Provide Their Views

17.8 Important Patient Sub-populations: Potential For Companies To Increase Market Leverage Through Product Differentiation

17.9 Improvements in Transplantation Success and Stem Cell Research will Reduce the Market for Insulin

18. Conclusion - Diabetes Is a Growing Market in Both Developed and Developing Countries

Appendix A: About visiongain

List of Tables

Table 2.1 Main Insulin Products Mentioned in the Report by Company, 2006

Table 2.2 Main Oral Anti-diabetic Products Mentioned in the Report by Company With US Patent Expiry Dates, 2006

Table 2.3 Diagnosis by the Fasting Plasma Glucose Test

Table 2.4 Top Ten Countries for Highest Estimated Cases of Diabetes, 2000 and 2030

Table 2.5 Leading Causes of Death in the US, 2002

Table 3.1 Types of Insulin

Table 4.1 Oral Anti-diabetic Drugs Currently Available

Table 5.1 Forecast Revenue ($m) and Growth Rate (%) for Insulin and Oral Anti-diabetics, 2004-2011

Table 5.2 Market Share of Insulin and Oral Anti-diabetics, 2005

Table 5.3 Market Share of Insulin and Oral Anti-diabetics, 2011

Table 5.4 Forecast Revenue ($m) and Growth Rate (%) for the Classes of Oral Anti-diabetics, 2004-2011

Table 5.5 Market Share of Insulin and Oral Anti-diabetics, 2005

Table 5.6 Market Share of Insulin and Oral Anti-diabetics, 2011

Table 5.7 Company Market Share (%), Insulin and Oral Anti-diabetic Drugs, 2005

Table 5.8 Company Market Share (%), Insulin and Oral Anti-diabetic Drugs, 2011

Table 5.9 Drug Prices ($) For Insulin and Oral Anti-diabetics, 2006

Table 6.1 Forecast Revenue ($m) and Growth Rate (%) for Insulin and Oral Anti-diabetics, 2004-2011

Table 6.2 Company Market Share (%) for the Thiazolidinedione Class, 2005 and 2011

Table 7.1 Table 7.1 Forecast Revenue ($m) and Growth Rate (%) for the Sulphonylureas, 2004-2011

Table 8.1 Forecast Revenue ($m) and Growth Rate (%) for the Biguanides, 2004-2011

Table 9.1 Forecast Revenue ($m) and Growth Rate (%) for the PGRs, 2004-2011

Table 10.1 Forecast Revenue ($m) and Growth Rate (%) for the AGIs, 2004-2011

Table 11.1 Forecast Revenue ($m) and Growth Rate (%) for the Incretin Mimetic Class, 2004-2011

Table 12.1 Total Diabetes Revenues (Oral and Insulins Combined) ($m) by Country, 2004

Table 12.2 Total Insulin Revenues ($m) by Country, 2004

Table 12.3 Total (Branded Only) Oral Anti-diabetic Drug Revenue ($m) by Country, 2004

Table 12.4 Market Share (%) for Insulins and Oral Anti-diabetic Drugs by Country, 2004

Table 12.5 Ratio of Insulin/Oral Use by Revenue (as %) Per Country, 2004

Table 12.6 US Revenues ($m) for Branded and Generic Oral Anti-diabetics, 2004

Table 12.7 Insulin Revenues ($m) From The US Market, 2004

Table 12.8 Company Revenue ($m) and Market Share (%) for Insulins on the US Market, 2004

Table 12.9 Japan Oral Anti-diabetic Market, 2004

Table 12.10 Japanese Oral Anti-diabetic Market Share (%) by Company, 2004

Table 12.11 Japanese Insulin Market ($m), 2005

Table 12.12 Japanese Insulin Market Share (%) by Company, 2004

Table 12.13 Revenues ($m) For The European Oral Anti- diabetic Market, 2004

Table 12.14 Market Share (%) for Branded and Generic Oral Anti-diabetic Drugs by European Country, 2004

Table 12.15 Revenues ($m) For The European Oral Anti- diabetic Market, 2004

Table 12.16 Revenues ($m) For The European Insulin Market, 2004

Table 12.17 Company Market Share (%) For Insulin Products for the European Market, 2004

Table 12.18 Diabetes Market Revenues ($m) for India and China, 2004

Table 12.19 Market Share (%) For Oral Anti-diabetics and Insulin For India and China, 2004

Table 13.1 Forecast Revenue ($m) and Growth Rate (%) of the World Insulin Market, 2004-2011

Table 13.2 Company Market Share (%) of the World Insulin Market, 2005

Table 13.3 Major Insulin Products by Company, 2006

Table 13.4 Company Market Share (%) of the World Insulin Market, 2011

Table 14.1 Leading Pipeline Products, 2005/6

Table 14.2 Agents for Diabetes in Phase III of Clinical Development

Table 14.3 Agents for Diabetes that Have Completed Phase III of Clinical Development

Table 14.4 Agents for Diabetes for Which Final Regulatory Approval Is Pending

Table 14.5 Other Agents in Clinical Development, by Country

Table 15.1 Syringes for Administering Insulin

Table 15.2 Insulin Pens Available in the US, 2006

Table 15.3 US Aids for Injection, 2006

Table 15.4 Types of US Insulin Jet Injectors, 2006

Table 15.5 US External Insulin Pumps, 2006

Table 17.1 Patent Expiration of the Leading Diabetes Treatments, 2006

List of Figures

Figure 5.1 Forecast Revenue ($m) for Insulin and Oral Anti-diabetics, 2004-2011

Figure 5.2 Growth Rates of World Diabetes Market ($bn), 2004-2011

Figure 5.3 Revenues ($bn) for Insulin and Oral Anti-diabetics, 2004-2011

Figure 5.4 Revenues ($bn) for Insulin and Oral Anti-diabetics, 2004-2011

Figure 5.5 Growth Rates (%) for Insulin and Oral Anti- diabetics, 2004-2011

Figure 5.6 Market Share (%) for Insulin and Oral Anti-diabetics, 2005

Figure 5.7 Market Share (%) for Insulin and Oral Anti-diabetics, 2011

Figure 5.8a Forecast Revenue ($m) for the Classes of All Oral Anti-diabetics, 2004-2011

Figure 5.8b Forecast Revenue ($m) for the Classes of Oral Anti-diabetics But Not Including the Thiazolidiones, 2004-2011

Figure 5.9 Market Share (%) for Oral Anti-diabetics, 2005

Figure 5.10 Market Share (%) for Oral Anti-diabetics, 2011

Figure 5.11 Company Market Share Insulin and Oral Anti- diabetic Drugs, 2005

Figure 5.12 Company Market Share Insulin and Oral Anti-diabetic Drugs, 2011

Figure 6.1 Forecast Revenue ($m) for the Thiazolidinedione Class of Oral Anti-diabetics, 2004-2011

Figure 6.2 Market Share (%) of the Thiazolidinediones, 2005

Figure 6.3 Market Share (%) of the Thiazolidinediones, 2011

Figure 7.1 Forecast Revenue ($m) for the Sulphonylurea Class of Oral Anti-diabetics, 2004-2011

Figure 7.2 Market Share (%) of the Sulphonylureas, 2005

Figure 7.3 Market Share (%) of the Sulphonylureas, 2011

Figure 8.1 Forecast Revenue ($m) the Biguanide Class of Oral Anti-diabetics, 2004-2011

Figure 9.1 Forecast Revenue ($m) the PGRs Class of Oral Anti-diabetics, 2004-2011

Figure 9.2 Market Share (%) of the PGRs, 2005

Figure 9.3 Market Share (%) of the PGRs, 2011

Figure 10.1 Forecast Revenue ($m) for the AGIs Class of Oral Anti-diabetics, 2004-2011

Figure 10.2 Market Share (%) of the AGIs, 2005

Figure 10.3 Market Share (%) of the AGIs, 2011

Figure 11.1 Forecast Revenue ($m) the Incretin Mimetic Class of Oral Anti-diabetics, 2004-2011

Figure 12.1 Total Diabetes Revenues (Oral and Insulins Combined) ($m) by Country, 2004

Figure 12.2 Total Insulin Market Share (%) by Country, 2004

Figure 12.3 Total (Branded Only) Oral Anti-diabetic Market Share (%) by Country, 2004

Figure 12.4 Market Share (%) for Insulins and Oral Anti-diabetic Drugs by Country, 2004

Figure 12.5 Ratio of Insulin/Oral Anti-diabetic by Revenue (as %) by Country

Figure 12.6 Market Share (%) for Branded and Generic Oral Anti-diabetics, 2004

Figure 12.7 Company Market Share (%) for Insulins on the US Market, 2004

Figure 12.8 Company Market Share (%) for Insulins on the Japanese Market, 2004

Figure 12.9 Market Share (%) For Branded and Generic Diabetes Drugs In The Leading EU Markets, 2004

Figure 12.10 Revenue ($m) of Leading Insulin Products in European Market, 2004

Figure 12.11 Company Market Share (%) For Insulin Products For the European Market, 2004

Figure 13.1 Forecast Revenues ($m) for the World Insulin Market, 2005-2011

Figure 13.2 Company Market Share (%) of the World Insulin Market, 2005

Figure 13.3 Company Market Share (%) of the World Insulin Market, 2011

Figure 13.3 Forecast Revenues ($m), For the Leading Insulin Products, 2004-2011

Figure 13.5 Company Market Share (%) of the Insulin Market, 2011

Figure 14.1 Patient Preference for Exubera Insulin

Figure 15.1 Locations for Injecting Insulin

Figure 17.1 SWOT Chart for the Diabetes Market, 2005-2011

Figure 18.1 The World Diabetes Market by Revenue ($m), 2004-2011